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Process Engineer

1 month ago

Cambridge, Massachusetts, United States Sequoia Biotech Consulting Full time
Job Title: Process Engineer

Sequoia Biotech Consulting is seeking an experienced Process Engineer to join our team. As a Process Engineer, you will be responsible for assisting with process engineering, process development, materials & engineering sciences, technology transfer, facilities/utilities/technical services, and manufacturing processes.

Key Responsibilities:
  • Assist with requirements specifications, design, functional requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit.
  • Lead start-up activities, including commissioning and qualification of facilities, utilities, and equipment (FUE).
  • Assist with risk assessments, feasibility reviews, risk mitigations, and testing of process materials to ensure compliance with manufacturing requirements.
  • Assist with the requirements specifications, design & development of process parameters, and the commissioning/validation of manufacturing processes for compliance with quality and regulatory requirements.
  • Provide technical support for the product/process lifecycle and related activities.
  • Support client requirements to lead or help process or engineering projects at vendors or other third-party contract companies, as needed.
  • Provide support for improvement projects regarding processes and systems.
  • Support or provide risk assessment and mitigation activities for process development, manufacturing, and testing as applicable.
  • Provide technical support for scale-up activities from development to manufacturing, including but not limited to technology transfers and facilities improvements (e.g., utilities/equipment integration).
  • Analyze and recommend improved technology to increase quality and efficiency.
  • Provide technical analysis and support for new or improved process systems.
  • Facilitate and schedule meetings with subject matter experts across the organization.
  • Ensure compliance with cGMP, regulatory, and industry standards.
Requirements:
  • Bachelor's degree in Engineering, Bio/Pharma Science, or a related technical field of study.
  • 4-7 years of related engineering and/or technical experience required.
  • Experience with cGMP Manufacturing within an FDA-regulated manufacturing company.
  • Knowledge of cGxP Quality Systems within an FDA-regulated manufacturing company.
  • Knowledge of FDA regulations and guidance or applicable regulatory standards and practices.
  • Proficient with MS Office suite, MS Project, Visio, and related electronic formats required to perform the respective job at a client.
  • Knowledge of laboratory and manufacturing systems such as LIMS, MES, etc.
  • Excellent computer, verbal, and written communication skills.
  • Innovative problem-solving skills and an integrated view of business/scientific issues.
  • Accountable and responsible individual to perform as intended for clients.
  • Willingness to travel to various clients when needed, with acceptable limitations during noted health pandemics or related constraints.
What We Offer:
  • Excellent healthcare options.
  • Medical, vision, prescription & dental.
  • Family Focus & Balance: Parental leave, flexible time-off and Employee Assistance Program.
  • Financial Security: 401(k) with employer matching.
  • Tuition Reimbursement: Continuing education for every season of your career.
  • Employee Recognition Programs.
  • Compensation: Our compensation reflects the cost of labor across several US geographic markets.